• Lead and continuously advance Loyal’s enterprise-wide GxP Quality Management System, ensuring compliance across GMP, GLP, and GCP domains. • Drive sustained inspection readiness, including strategic preparation for FDA CVM Pre-Approval Inspections (PAIs) and other global regulatory inspections. • Provide executive oversight of GCP quality systems, including clinical trial governance, CRO oversight, TMF compliance, protocol adherence, vendor qualification, and audit readiness for active and future studies. • Ensure robust GMP oversight across CMC development, manufacturing partners, testing laboratories, and commercial supply activities. • Oversee GLP compliance for pivotal laboratory-based studies and CROs. • Lead enterprise audit strategy, including internal audits, supplier audits, clinical site audits, and mock regulatory inspections. • Establish and maintain quality agreements and oversight frameworks for CDMOs, CROs, testing laboratories, and other GxP vendors. • Provide executive oversight of deviations, investigations, CAPAs, change controls, and risk management processes to ensure timely and defensible resolution. • Develop and monitor quality metrics and dashboards to provide executive visibility into compliance performance and organizational risk. • Serve as the primary quality representative during regulatory inspections and interactions with FDA CVM and other global animal health authorities. • Recruit, build, and lead a high-performing QA organization with scalable governance structures and clear accountability. • Foster a proactive, risk-based quality culture that supports operational agility while maintaining regulatory rigor.